Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
On December 18, 2025, the FDA approved Formycon and Zydus’s Nufymco™ (ranibizumab-leyk) as the third interchangeable biosimilar of Genentech’s Lucentis® (ranibizumab). Lucentis® biosimilars have been on the market since July...more
On December 19, 2025, the FDA approved Amneal / mAbxience’s Boncresa™ / Oziltus™ (denosumab-mobz) as the nineth biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
In March 2025, West Virginia passed one of the most aggressive Make America Healthy Again (MAHA)-inspired statutes in the country banning a number of FDA-approved food dyes. But its future is now uncertain after a federal...more
On December 22, 2025, the FDA approved mAbxience and Amneal’s Biologics Licensing Applications (BLAs) for BONCRESA™ (denosumab-mobz) and OZILTUS™ (denosumab-mobz), biosimilars referencing Amgen’s PROLIA® (denosumab) and...more
In this collaborative analysis, Vicente LLP and the preeminent FDA law firm Kleinfeld, Kaplan & Becker LLP examine how the potential reclassification of cannabis into Schedule III could impact its distribution and dispensing....more
A new Food and Drug Administration ("FDA") pilot opens the door for digital health devices without FDA premarket authorization to be used to provide care paid under the Center for Medicare and Medicaid Innovation ("CMMI")...more
On December 3, 2025, Celltrion announced that the FDA has approved a new dose of OMLYCLO (omalizumab-igec), the first and only biosimilar designated as interchangeable with Genentech and Novartis’s XOLAIR (omalizumab). The...more
The U.S. Food and Drug Administration (FDA) has approved a significant update to the prescribing information for Depo-Provera, adding a warning about a potential association with meningiomas, a type of brain tumor. This marks...more
On June 17, 2025, FDA Commissioner Marty Makary launched a new priority review pilot program intended to accelerate FDA review for drug and biologic companies supporting U.S. national interests. Specifically, the...more
In 1995, the Michigan Legislature enacted its Drug Immunity Law, which provided an absolute defense for pharmaceutical companies in product liability suits stemming from the safety and efficacy of their drug products, the...more
The U.S. Food and Drug Administration (FDA) on Dec. 11, 2025, announced a proposed administrative order to add bemotrizinol as a new active ingredient to the over-the-counter (OTC) sunscreen monograph. This is the first new...more
On December 4, 2025, the FDA approved a new indication for Bristol Myer Squibb’s BREYANZI (lisocabtagene maraleucel) for the treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed...more
A recent preemption decision out of the Southern District of New York offers encouraging news for medical device manufacturers. In Wieder v. Advanced Bionics LLC, 2025 WL 3237257 (S.D.N.Y. Nov. 20, 2025), the magistrate judge...more
On November 20, 2025, the FDA approved Accord’s Osvyrti® and Jubereq® (denosumab-desu), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne). ARMLUPEG is approved as a 6 mg/0.6 mL single-dose prefilled syringe presentation, referencing...more
On November 17, 2025, Sandoz and Polpharma announced the U.S. launch of Tyruko® (natalizumab-sztn), the first and only FDA-approved biosimilar to Biogen’s Tysabri® (natalizumab) and the first biosimilar available to treat...more
On November 13, 2025, the FDA approved Shanghai Henlius Biotech / Organon’s Poherdy® (pertuzumab-dpzb) as the first interchangeable biosimilar of Genentech’s Perjeta® (pertuzumab). Poherdy® is approved for all of the same...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
FDA Commissioner Martin Makary and Center for Biologics Evaluation and Research Director Vinay Prasad recently published an article in the New England Journal of Medicine (“NEJM”) outlining the guiding principles of a new...more
On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis. TYRUKO® was approved by FDA in...more
On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively. This marks the eighth set of...more
On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application (“sBLA”) for Dupixent (dupilumab) in the treatment of adults and children aged 6...more
In this era of industrialized capitalism, there are serious economic incentives to promote products in nascent industries. Intellectual property and the corresponding legal framework help achieve this promotion. ...more
On November 6, 2025, Amgen filed its eighth and ninth BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-17277 (D.N.J.) against Alvotech and Dr. Reddy’s AVT03 and Case No....more
The Food and Drug Administration (FDA) has issued a statement, published electronically in the New England Journal of Medicine (NEJM) on November 12, 2025, proposing a new process for obtaining marketing authorization for...more